FDA OSEL Medical Extended Reality Program: Advancing evaluation methods and regulatory science tools

TALK OVERVIEW
In this presentation, we will summarize the landscape of medical devices using augmented and virtual reality technology and discuss the current evaluation gaps and challenges for medical extended reality. In the second part of the presentation, we will give an overview of our recent regulatory science research. Finally, we will present our efforts to develop publicly available regulatory science tools intended to reduce the regulatory burden through standardized methodologies for evaluating safety and effectiveness of medical devices.
SPEAKERS
Ryan Beams
Physicist, US Food & Drug Administration
Chumin Zhao Ph.D.
Staff Fellow, US Food and Drug Administration
Miguel Lago Ph.D.
Staff Fellow , US Food and Drug Administration
MODERATOR
Veena Somareddy
CEO at Neuro Rehab VR
Chapters:
(01:18) - Current Evaluation Gaps and Methods for Evaluating VR and AR Medical Devices
(06:12) - Use of WebXR Platform for Developing Regulatory Science Tools
(14:54) - Technical and Clinical Aspects of Evaluation
(17:41) - OSEL's Medical Extend Reality Program
(29:53) - Augmented Reality for Surgical Applications
(35:54) - Challenges in Developing VR Applications
(38:53) - VR Immersive Mode and Testing Across Headsets
(40:21) - Audience Feedback and Questions
(41:29) - OSEL as a Testing Lab and FDA Collaboration
(45:57) - Separation of Hardware and Software
(50:09) - Importance of Diverse Teams in Design